MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PCO8VP

Device Problems Component Missing (2306); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, preoperatively on a laparoscopic repair of ventral hernia by intraperitoneal mesh placement on the umbilical hernia, after opening the packaging, the device was damaged and had a 3cm defect and the surgeon saw that a part of the collagen gel was missing.There was no patient involvement.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - OPTIMIZED COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7651314
• MDR Text Key: 112850422
• Report Number: 9615742-2018-01400
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521514164
• UDI-Public: 10884521514164
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: PCO8VP
• Device Catalogue Number: PCO8VP
• Device Lot Number: PRC0690X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1